Tina
★    

India,
2013-09-12 16:20
(4675 d 07:09 ago)

Posting: # 11484
Views: 1,741
 

 Development Safety Update Report requirement [Regulatives / Guidelines]

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Dear members,

A BE has been planned to be conducted in France. The BE study has a washout period of 30 days. The entire BE study will be completed within 50 days. Is a DSUR required for this study? I thought DSURs are required for study with active molecule whose study period extend beyond a year.Request the experts to guide please.
 
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